Condition category
Oral Health
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
20/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Fenlon

ORCID ID

Contact details

Dental Prosthetics
Room 304
25th Floor
Guy's Tower
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 7479
michael.fenlon@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013146125

Study information

Scientific title

Acronym

Study hypothesis

That there is no difference between the success of and impact on oral health of patients of lower cobalt chromium distal extension saddle partial dentures and single cantilever distal extension resin bonded bridges.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Oral Health

Intervention

Patients suitable for cobalt chromium lower distal extension saddle partial dentures made at Guy's Hospital will be randomised into two groups:
1. One group will have the dentures
2. The other will have one or two distal cantilever minimum preparation resin bonded bridges
The success, ongoing problems, maintenance requirements and impact on oral health of the different restorations will be monitored over 5 years.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Fit of dentures
2. Need for adjustment,
3. Acceptability
4. Patient wear of dentures

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2004

Overall trial end date

30/09/2007

Reason abandoned

Lack of funding

Eligibility

Participant inclusion criteria

100 patients attending Guy's Hospital for prostheses for edentulous distal extension saddle areas.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/2004

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dental Prosthetics
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Guy's and St. Thomas' NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own account - NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes